41916 Federal Register / Vol. 74, No. 159 / Wednesday, August 19, 2009 / Notices 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: August 12, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–19879 Filed 8–18–09; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel, Clinical Trials and Planning 

Grants. 

Date: September 9, 2009. 

Time: 10 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge 6700, 6700B Rockledge Drive, 

Bethesda, MD 20817 (Telephone Conference 

Call). 

Contact Person: Brenda Lange-Gustafson, 

PhD, Scientific Review Officer, NIAID/NIH/ 

DHHS, Scientific Review Program, Room 

3122, 6700–B Rockledge Drive, MSC–7616, 

Bethesda, MD 20892–7616, 301–451–3684, 

bgustafson@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: August 12, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–19877 Filed 8–18–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Methodologies for Post-Approval 

Studies of Medical Devices; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public workshop entitled 

‘‘Methodologies for Post-Approval 

Studies of Medical Devices.’’ The 

purpose of the workshop is to facilitate 

discussion among FDA, industry, 

academia, professional societies, 

clinical investigators and other 

interested parties on issues related to 

methodologies for post-approval studies 

of medical devices. The target audiences 

for this workshop are Epidemiologists, 

Statisticians, Clinicians and Regulatory 

Affairs Specialists. 

Dates and Times: The workshop will 

be held on September 9, 2009, from 9 

a.m. to 5 p.m. and September 10, 2009, 

from 9 a.m. to 5 p.m. Participants are 

encouraged to arrive early to ensure 

time for parking and security screening 

before the meeting. Security screening 

will begin at 8 a.m., and registration will 

begin at 8:30 a.m. Please pre-register for 

the workshop by following the 

instructions in this document. 

Location: The workshop will be held 

at the FDA White Oak Campus, 10903 

New Hampshire Ave., Silver Spring, MD 

20993. 

Contact Persons: Daniel Can ̃ os, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., WO66/Room 

4120, Silver Spring, MD 20993, 240– 

796–6057, daniel.canos@fda.hhs.gov ; or 

Ellen Pinnow, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., WO66/Room 4106, Silver Spring, 

MD 20993, 301–796–6066, 

ellen.pinnow@fda.hhs.gov 

Registration: To register for the 

conference please visit the following 

Web site: https://medsun2.S-3.net/ 

FDAPASWkshpSep09. There is no fee to 

attend the workshop, but attendees must 

register in advance. The registration 

process will be handled by Social and 

Scientific Systems, which has extensive 

experience in planning, executing, and 

organizing educational meetings. 

Although the facility is spacious, 

registration will be on a first-come, firstserved basis. In-person attendance is 

limited to 120 participants. You may 

also register to attend the meeting via 

webcast. Non-U.S. citizens are subject to 

additional security screening, and they 

should register as soon as possible. If 

you need special accommodations 

because of a disability, please contact 

Daniel Can ̃ os (see Contact Persons) at 

least 7 days before the public workshop. 

SUPPLEMENTARY INFORMATION: 

I. Why Are We Holding This Public 

Workshop? 

The purpose of the public workshop 

is to facilitate discussion among FDA 

and other interested parties on 

methodological issues related to PostApproval Studies for medical devices. 

II. What Are the Topics We Intend To 

Address at the Public Workshop? 

We hope to discuss a large number of 

issues at the workshop, including, but 

not limited to: 

• Regulatory requirements for 

conducting Post-Approval Studies for 

medical devices; 

• Using existing infrastructure (e.g., 

registries) to facilitate Post-Approval 

Studies; 

• Using innovative study design 

strategies and advanced epidemiologic 

methods to enhance and facilitate PostApproval Studies; 

• Review important measurement 

considerations inherent to PostApproval Studies; 

• Clinical research organizations, 

industry, academia, and other clinical 

trial consultant’s perspectives on all of 

the previous issues related to PostApproval Study methodologies for 

medical devices. 

III. Where Can I Find Out More About 

This Public Workshop? 

Background information on the public 

workshop, registration information, the 

agenda, information about lodging, and 

other relevant information will be 

posted, as it becomes available, on the 

Internet at http://www.fda.gov/cdrh/ 

meetings.html. 

Dated: August 12, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. 09–19904 Filed 8–18–09; 8:45 am] 

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